CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,408 enrolled
Drug / intervention
Anti-hypertensive therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02299414
NCT02299414Phase 4Completed
CompareCT.gov

A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project

University of Alabama at Birmingham·interventional·Posted Nov 24, 2014·Updated May 17, 2023

In Brief

A Phase 4 clinical trial evaluating Anti-hypertensive therapy and No anti-hypertensive therapy (unless BP is severe) for Hypertension. Completed, enrolled 2,408 participants across 72 sites.

Detailed Summary

The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (\<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
CollaboratorsColumbia University, Drexel University College of Medicine, Rutgers, The State University of New Jersey, Lehigh Valley Hospital, Saint Peters University Hospital, Christiana Care Health Services, Washington University School of Medicine, Duke University, University of Texas Southwestern Medical Center, The University of Texas Health Science Center, Houston, Stanford University, University of Pennsylvania, The University of Texas Medical Branch, Galveston, University of Utah, Intermountain Health Care, Inc., University of California, San Francisco, Johns Hopkins University, University of Pittsburgh, Ochsner Health System, University of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI), WakeMed Health and Hospitals, San Francisco General Hospital, McKay-Dee Hospital, Winthrop University Hospital, New York Hospital Queens, Latter Day Saints Hospital, Lyndon B Johnson General Hospital, Virtua Medical Group, Duke Regional Hospital, Utah Valley Regional Medical Center, Northwestern University, Women and Infants Hospital of Rhode Island, Baylor College of Medicine, Case Western/Metro Health, Ohio State University, University of Iowa, University of California, San Diego, Indiana University, Meriter Foundation, Weill Medical College of Cornell University, University of Oklahoma, Medical University of South Carolina, Beaumont Hospital, University of Colorado, Denver, University of Kansas Medical Center, Denver Health and Hospital Authority, Gundersen Health System, Wake Forest University Health Sciences, Oregon Health and Science University, Medical College of Wisconsin, Temple University, New Jersey Medical School, University of South Alabama, Vanderbilt University, University of Arkansas, Emory University, St. Luke's Hospital and Health Network, Pennsylvania, The Cleveland Clinic, University of Tennessee, TriHealth Inc., Tulane University, Yale University, Arrowhead Regional Medical Center, Geisinger Clinic, Miami Valley Hospital

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 24, 2014
Enrollment StartJun 1, 2015
Primary CompletionApr 1, 2022
Study CompletionDec 16, 2022
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 11.6 years ago

Interventions

Anti-hypertensive therapydrug

1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)

No anti-hypertensive therapy (unless BP is severe)other

Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.